WO2017197193A1 - Thermal-stable whipped formulations - Google Patents
Thermal-stable whipped formulations Download PDFInfo
- Publication number
- WO2017197193A1 WO2017197193A1 PCT/US2017/032277 US2017032277W WO2017197193A1 WO 2017197193 A1 WO2017197193 A1 WO 2017197193A1 US 2017032277 W US2017032277 W US 2017032277W WO 2017197193 A1 WO2017197193 A1 WO 2017197193A1
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- WO
- WIPO (PCT)
- Prior art keywords
- formulation
- package
- whipped
- active agents
- sunscreen
- Prior art date
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/02—Cosmetics or similar toiletry preparations characterised by special physical form
- A61K8/04—Dispersions; Emulsions
- A61K8/046—Aerosols; Foams
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23P—SHAPING OR WORKING OF FOODSTUFFS, NOT FULLY COVERED BY A SINGLE OTHER SUBCLASS
- A23P30/00—Shaping or working of foodstuffs characterised by the process or apparatus
- A23P30/40—Foaming or whipping
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K47/02—Inorganic compounds
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- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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- A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
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- B—PERFORMING OPERATIONS; TRANSPORTING
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- B65D83/00—Containers or packages with special means for dispensing contents
- B65D83/14—Containers or packages with special means for dispensing contents for delivery of liquid or semi-liquid contents by internal gaseous pressure, i.e. aerosol containers comprising propellant for a product delivered by a propellant
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Definitions
- This invention relates to the field of whipped or whippable formulations. More specifically, the invention relates to thermal-stable whipped or whippable formulations.
- the formulation comprising one or more active agents and one or more thermal stabilizing agents; the formulation is co-mingled (co- processed) with a gas propellant under controlled temperature and under pressure into a package; wherein the gas propellant is added in sufficient amounts to be dispersed in the formulation.
- the pressurized package is under
- FIG. 7 shows appearance and stability of "whipped- foam” delivered from whipped after sun formulations containing different amount of behenyl alcohol, which had been stored at 40°C/75%RH for 1 day.
- the word “a” or “plurality” before a noun represents one or more of the particular noun.
- the phrase “and without limitation” is understood to follow unless explicitly stated otherwise.
- the term “about” is meant to account for variations due to
- the pressurized package is under sufficient pressure suitable to maintain the first gas propellant dispersed in the formulation. In certain embodiments, the pressurized package is under
- the component comprises one or more second gas and/or liquid propellant; the generating and maintaining component is present in the package in sufficient amounts and pressure to expel the formulation as a whipped formulation upon application of external force on the
- the disclosed whipped formulation may be referred to herein as whipped formulation, whipped formulation product, whipped product, and the like.
- the disclosed whippable formulation may be referred to herein as whippable formulation, whippable formulation product, whippable product, and the like.
- can may be used to also mean “package.”
- a subject may be a human subject (user) or may be an animal subject (user) .
- the terms "subject” and “user” are used interchangeably .
- disclosed herein comprise one or more active agents for each of the above formulations.
- the whipped formulation product is a skincare product, comprising one or more skincare active agents.
- the whipped formulation product is a sunscreen or an after-sun product.
- the whipped formulation product may be an oral dosage form, such as a whipped multi-vitamin product.
- the whipped formulation product may be for
- a subject may be a human subject (user) or may be an animal subject (user) .
- Subject and “user” are used
- the formulation further comprises a foaming agent. In certain embodiments, the
- formulation is for topical application.
- the pressurized package in which pressure may be generated and/or maintained sufficient for the disclosed formulations is a Bag-on-valve, Piston Can, or Bag-in-Can.
- the pressurized package is a mechanical pressure system, including for example, bladder system (such as Exxal Atomos System), which is a PowerContainer system with a rubber bladder around the outside providing pressure to the internal volume.
- bladder system such as Exxal Atomos System
- PowerContainer system with a rubber bladder around the outside providing pressure to the internal volume.
- springs are used to exert pressure on a bag.
- hydrostatic pressure is used to exert pressure on a bag .
- the package is a bag on valve (BOV) pressurized assembly, comprising a two-way fill/dispensing valve, an attached internal high barrier bag affixed to the valve, and rigid container adapted to and capable of holding positive pressure, affixed to the valve.
- the container is glass, barrier resin, metal/alloy, or another material capable of holding positive pressure.
- the container is pre- pressurized with one or more gas and/or liquid propellants prior to filling.
- the BOV pressurized assembly dispenses the whipped product in a metered dispensing system and not a continuously dosing system.
- the pressurized package can comprise a "pressure generating and maintaining component, " which may be a component that generates and/or maintains pressure in the package. It may refer to a chemical component or components which generate pressure, e.g., compressed gas, while inside an enclosed package, device or container (such as a can, for example) .
- pressure generating and maintaining components are compressed gases/propellants and liquid propellants such as, for example, CO2, propane, butane, isobutane, dimethyl ether, nitrous oxide, nitrogen, oxygen, air and the like, and suitable blends of such propellants.
- a valve is opened by applying an external force, the formulation or ingredients in the device are dispensed in a 'whipped' form or a foamy form. This chemical component or components does not co-mingle with the formulation.
- pre-pressurizing the package is not needed.
- the package is under Zero Cut Bag Pressure, where gas is present around bag but not pressurized above ambient. Filling the package at ambient pressure, the pressure inside the package would increase as the BOV expands.
- the package comprises an elastomeric tube/bag (akin to a tied off surgical tube) .
- a slight vacuum is applied.
- the package is pressure agnostic, in which the container cannot hold pressure around the bag.
- the package has Negative Cut Bag Pressure, where vacuum is present around the bag but not pressurized above ambient. Other such systems may be used, such as the Sterilflo ® system (https : //www.hydrasense . ca/en/why-choose- hydrasense/steriflo/ ) .
- a “skincare active agent” includes all those materials which are regarded as acceptable for use as active skin- protecting ingredients.
- a skincare active agent includes, for example and without limitation, skin protectant and/or anti- aging agent. Approval by a regulatory agency may sometimes be required for inclusion of active agents in formulations intended for human contact including but not limited to sunscreen active ingredients or petrolatum, white petrolatum, mineral oil, and dimethicone as skin protectants, as well as agents used as self- tanners or for diaper rash treatment and the like.
- sunscreen active ingredients are accepted for use in other countries. Some non-limiting examples from outside the U.S.
- Tinosorb M Tinosorb S
- Uvinul T- 150 UVA sorb HEB
- Uvinul A Plus Neo Heliopan AP
- Neo Heliopan MBC Neo Heliopan MBC
- the amount of skincare active agent or agents is present in an amount that is consistent with the FDA guidelines.
- the use of a combination of active agents is especially true for sunscreen formulations in order to achieve higher levels of ultraviolet absorption or to provide useful absorption over a wider range of ultraviolet wavelengths than can be the case with a single active component.
- the sunscreen active agent or agents is present in an amount that is consistent with the FDA sunscreen monograph for sunscreen active agent or agents that are believed to provide the requisite SPF in accordance with the FDA monograph for such sunscreens.
- Other skin care active agents include sunless tanning active agents, skin protectant active agent emollients, insect repelling agents, and the like. And other agents known in the art.
- sun product After sun product is specially formulated to cool, soothe, calm, and re-hydrate (moisturize) a sunburnt or stressed skin, and to lessen the pain or itch of a sunburnt body.
- an After Sun formulation contains Glycerin, Panthenol, and Aloe Barbadensis Leaf Juice to provide cool and moisturizing effects on skin.
- another After Sun formulation contains Lidocaine as an active to provide sunburn pain/itch relief.
- active agents include, for example and without limitation, sunscreen active agents, after sun active agents, vitamins, food, etc. Any active agents that can be included as a whipped formulation or a whippable formulation are within the scope of this invention. These agents are known in the art .
- the thermal stabilizing agent (s) is a long chain alcohol that is 18 carbon or longer, and/or a microcrystalline cellulose based product selected from one or more product selected from a purified, partially
- the long chain alcohol is behenyl alcohol.
- the microcrystalline cellulose based product is Avicel RC-591.
- the formulation is an
- Thermal-stable whipped formulation is a formulation that remains in its whipped form after being expelled from the package after storage and/or during use at a range of
- the formulation remains stable after the formulation is expelled from the package after storage at a temperature up to about 50°C. In certain embodiments, the formulation remains stable after the formulation is expelled from the package after storage at a temperature between about - 10°C and about 50°C. In certain embodiments, the formulation remains stable after the formulation is expelled from the package after storage for at least about 1 day. In certain embodiments, the formulation remains stable after the
- formulation is expelled from the package after storage for at least about 2, 3, 4, 5, 6, 7, 8, 9, or 10 days, or more.
- the formulation remains stable after the formulation is expelled from the package after storage for at least 1 day at a temperature between about -10°C and about 50°C.
- the formulation is a sunscreen and the one or more active agents include one or more sunscreen active agents.
- the formulation is a sunscreen and the one or more active agents include one or more sunscreen active agents; and the formulation remains stable after storage for at least 1 day to up to one month at a
- the formulation comprising between about 1.2% w/w to about 8.7% w/w behenyl alcohol.
- the formulation is an after sun formulation and the one or more active agents include one or more after sun active agents; and the formulation remains stable after storage for at least 1 day at a temperature up to about 50°C, wherein the formulation comprises between about 1.0% w/w to about 7.5% w/w behenyl alcohol.
- the formulation is N-(2-aminoethyl)-2-aminoethyl-N-(2-aminoethyl)-2-aminoethyl-N-(2-aminoethyl)-2-aminoethyl-N-(2-aminoethyl)-2-aminoethyl-N-(2-aminoethyl)-2-aminoethyl
- the formulation is characterized by microdispersion and gas propellant level above normal saturation.
- the formulation is characterized by substantially consistent microvoid after the formulation is expelled from the package.
- the formulation is highly emollient after the formulation is expelled from the package.
- the formulation is readily spreadable and spreaded evenly after the formulation is expelled from the package.
- the gas propellant (co-mingled or co-processed with the formulation comprising one or more active agent) is nitrogen, nitrous oxide, carbon dioxide, Argon, air or oxygen. In certain embodiments, the gas propellant in the formulation is between about 0.01% w/w to about 15.00% w/w.
- the formulation has one or more of characteristics such as little or no wetness after application, having a collapse time of at least 60 seconds, or structurally stable for at least 30 minutes.
- the formulation is a sunscreen and the one or more active agents include one or more sunscreen active agents.
- Non-shear thickening emulsion chemistry developed to allow for high levels of gas saturation, physical stability during temperature and pressure extremes, and post-dispensing foam stability.
- the chemistry has also been customized to allow for the inclusion of consumer-relevant ingredients that may include, for example and without limitation, sun screen actives, moisturizers, emulsifying agents, film forming agents,
- thickening agents thickening agents, skin feel aesthetic enhancers, antifungals, pH adjusters, pro vitamin additives, physical skin barriers, anti-bacterial agents, skin colorants, etc.
- Other ingredients are also contemplated, such as, without limitation, pain relief additives .
- the blended formulation is transferred into a hopper, pressurized and under a controlled temperature; rate of flow and pressure is
- Pre-mixing step Co-process of a base formulation (Concentrate) and a 1st Gas.
- Pre-pressurizing step Pressurizing of a 2nd gas between a bag and the inside wall of the product package.
- Packaging step Packaging the pre-mixed formulation (concentrate + the 1st gas) into the pre-pressurized Bag on Valve (BOV) package.
- a blended base formulation is transferred into a hopper, pressurized and under a controlled temperature, rate of flow and pressure is transferred into a high shear, continuous-flow, high-pressure "whipping" head, which rapidly mixes the base formulation with a series of infusion gas injector ports which controls the gas pressure and rates of flow with a selection of gases (or gas) to rapidly co-mingle the gas
- the gas propellant co-mingled with the formulation prior to filling the formulation/gas into the package is nitrous oxide gas.
- the Nitrous Oxide in the formulation is 0.1% w/w -4.0% w/w. In certain embodiments, the Nitrous Oxide in the formulation is about 0.1% w/w - about 10.0% w/w. In certain embodiments, the Nitrous Oxide in the formulation is about 0.1% w/w -about 1.9% w/w. In certain embodiments, the Nitrous Oxide in the
- formulation is about 0.1%, 1.0%, 1.9%, 2.0%, 3.0%, 4.0%, 5.0% w/w to about 6%, 7%, 8%, 9%, 10 w/w.
- Nitrous Oxide has a slight sweet odor that can
- certain other gases can serve as a particularly good whipping agent, as evaluated by the known or estimated Ostwald Coefficients of the blended mixture and gases. Taking into consideration the potential negative effects of co-mingling of the gases with base blended formulation, example being CO2, which can react with water-containing formulas to create carbonic acid and cause shifts in product pH.
- CO2 can be used as a whipping gas to deliberately modify the pH of the formulation to reach targeted pH levels.
- Gas propellant or combinations include, without limitation, CO2, argon, isobutane, nitrogen, Argon, air, oxygen, isopentane, hydrofluroolefin, other suitable gases, and combination thereof.
- the gas propellant in the formulation is between about 0.01% w/w to about 15.00% w/w.
- pressurized package is between about 15psig to about 60psig. In certain embodiments, the final pressure in the pressurized package is between about 80psig to about 160psig. In certain embodiments, the pressure is about 40psig.
- the package is a Bag on Valve
- BOV high barrier bag pressurized assembly, comprising a two way fill/dispensing valve, an attached internal high barrier bag (affixed to valve) , and rigid container capable of holding positive pressure
- the container may be glass, barrier resin, metal/alloy, or another material capable of holding positive pressure.
- the container may be "pre-pressurized” with a combination of gaseous and/or liquid propellants prior to filling, with internal pressure expected to build as the
- the Bag on Valve assembly and accompanying "air gap" created between bag and the pressurized rigid container help to create an insulated barrier between the formulation and the user environment.
- This isolative barrier is helpful to moderate the temperature swings that might be experienced when taking this product from an ambient (indoor) location to a cooler or warmer environment, such as into the sun or into vehicles located in low/high temperature environments.
- This barrier helps to buffer formulation temperature change and help the formulation deliver a more consistent product experience (lower temperatures can form more rigid foam structures and high temperatures can cause weaker foam structures) .
- This feature can be particularly useful for products formulated with lower melt point foam-formers, intended for use in elevated temperature environments.
- Bag on Valve delivery systems differ from traditional aerosol delivery systems in at least the following district ways: Aerosols require propellant gases to be co-joined or co- mingled into the base formulation, as would be the case in single or multiphase system. These systems use the propellant gas to both expel the product and as a foaming and/or particle breakup agent.
- a Bag on Valve system includes the use of a bag within a metal can. The bag is in direct contact with the single phase formulation and is expelled by application of pressure to the outside of the bag. As such, the propellant gas inside the package never comes in contact with the product. Particle breakup or foaming can be accomplished through the dispensing actuator design and/or through the inclusion of a secondary gas within the formulation.
- This BOV design has a several distinct benefits over traditional aerosol systems including without limitation:
- Nitrous Oxide is used as a whipping agent without allowing "free gas" to be expelled and potentially abused.
- whipped cream packaging which is sold in a traditional aerosol permits the user the ability to release and potentially abuse the gas propellant/whipping agent.
- the pressure generating and maintaining component may be a gas, such as gaseous propellant, a liquid, such as a liquid propellant or a blend of gas and liquid.
- a gaseous propellant may also be a compressed gas, such as CO2, nitrous oxide and the like.
- a liquid propellant may also be a liquefied gas, such as isobutane and the like.
- the pressure generating and maintaining component can be formulated inside the device in a variety of ways, depending upon the nature of the component or components that form the pressure generating and maintaining component.
- the vehicle while acting as pressure-generator, may be a gas, even though it may have been packaged as, for example, a gas, a liquid or a solid.
- Non-limiting examples of the gas are carbon dioxide
- the gas could be pumped into the container, or it could be added into the ingredients as "dry ice", or it could be derived or generated in situ via the chemical reaction of a suitable base with a suitable acid.
- the gas In the case of "pumped in” or “dry ice”, the gas is already present as CO2.
- the gas In the case of generation in situ via the chemical reaction of a base with an acid, the gas is generated when the acid and the base mix.
- Suitable bases include sodium bicarbonate, sodium carbonate, potassium
- bicarbonate, potassium carbonate and the like are examples of suitable acids.
- suitable acids include acetic acid, citric acid and the like.
- Sodium bicarbonate with citric acid is a suitable combination. Because the components are being combined inside of the sealed container (device) , the gas produced during the reaction is trapped which pressurizes the container.
- One advantage of the inventive system is that the gas introduced or produced may be non-flammable.
- the whipped formulation product is characterized by microdispersion and gas propellant level above normal saturation. In certain embodiments, the whipped formulation product is characterized by substantially consistent microvoid.
- the whipped formulation product comprises at least one recognized skincare active agent.
- the whipped formulation is a sunscreen formulation comprising at least one sunscreen active agent .
- the whipped formulation product further comprises other ingredients, such as, for example and without limitation, one or more fatty alcohols - selected from, for example and without limitation, cetyl
- the whipped formulation is an after sun lotion (contains Cetyl alcohol) but optionally without any added behenyl alcohol.
- the physical stability of the whipped products obtained may also be characterized by means of these tests : determination of the organoleptic characteristics (e.g., aspect, color, odor), characterization of the texture (e.g., thick, fluid, greasy, non-greasy), and characterization of the spreadability .
- organoleptic characteristics e.g., aspect, color, odor
- characterization of the texture e.g., thick, fluid, greasy, non-greasy
- the disclosed whipped product formulation dispenses in a continuous stream when an external pressure is applied to the device, such as by depressing the valve/actuator, thereby eliminating the need to sgueeze and shake the formulation out of a bottle or tube.
- the disclosed whipped product in its device operates as a "one-touch" delivery system; in such system, the user will hold down the actuator until the desired amount of formulation is dispensed.
- the disclosed whipped product in its package offers a continuous delivery system for an application, such as, for example and without limitation, skincare applications and suncare applications.
- an application such as, for example and without limitation, skincare applications and suncare applications.
- continuous delivery is typically offered as a spray product and has been very successful due to the ease and speed that it provides for sunscreen application.
- sunscreen application Many consumers, however, prefer lotions/gels over sprays and would benefit from a continuous delivery mechanism.
- the present invention offers such an advantage.
- the disclosed whipped formulation product can be used for any application that would benefit from such product, including, for example and without limitation, skincare, sunscreen, after sun care, vitamins, woundcare, etc.
- the formulation needs to comprise the corresponding active agent (s) and may further comprise other appropriate ingredients .
- the disclosed whipped product dispenses in a light whipped form, infused with tiny bubbles that make the texture of the formulation lighter, smoother and easier to spread across the skin.
- This texture also makes the formulation feel less greasy and more aesthetically pleasing on hands and skin, leaving a 'sumptuous' feel with a sun-screen during application.
- This formulation spreads quickly and disappears rapidly as the user rubs the formulation into the skin. Such a formulation may even prevent excess application of the agent and may offer ecological advantages.
- the disclosed whipped product offers an easier, faster, smoother, and less greasy skincare formulation than a traditional formulation.
- emulsion identifies oil-in-water (o/w) or water-in-oil (w/o) type dispersion formulations intended for application to the skin, and air emulsion.
- Such dispersion formulations include, for example and without limitation, lotions and creams providing cosmetic or therapeutic benefits.
- the emulsions may contain any of a number of desired "active" ingredients, including skin colorants, drug substances (such as anti-inflammatory agents, antibiotics, topical anesthetics, antimycotics , keratolytics , etc.), skin protectants or
- conditioners conditioners, humectants, ultraviolet radiation absorbers, food, vitamins, etc., depending on the intended uses for the
- the whipped formulation product comprises one or more of a thickening agent and/or an emulsifying agent.
- Suitable emulsifiers are those known in the art for producing oil-in-water type emulsions.
- An aqueous external phase is preferred by many people for skin contact, since it is not as likely to produce an oily or greasy sensation when it is being applied, as is an emulsion having an oil external phase.
- the typical oil-in-water emulsifier has a hydrophilic-lipophilic balance (frequently abbreviated as "HLB") value greater than about 9, as is well known in the art; however, this "rule” is known to have numerous exceptions.
- HLB hydrophilic-lipophilic balance
- the chosen emulsifier depending upon its chemical nature, will be a component of either the oil or aqueous phase or both, and assists with both the formation and the maintenance, or stability, of the
- Non-limiting examples of suitable emulsifiers or surfactants include pharmaceutically acceptable, non-toxic, non- ionic, anionic and/or cationic surfactants.
- suitable non-ionic surfactants include, for example and without
- glycerol fatty acid esters such as glycerol
- glycol fatty acid esters such as propylene glycol monostearate
- polyhydric alcohol fatty acid esters such as polyethylene glycol (400) monooleate
- polyoxyethylene fatty acid esters such as polyoxyethylene (40) stearate
- polyoxyethylene fatty alcohol ethers such as polyoxyethylene (20) stearyl ether
- polyoxyethylene sorbitan fatty acid esters such as
- polyoxyethylene sorbitan monostearate polyoxyethylene sorbitan monostearate
- sorbitan esters such as sorbitan monostearate
- alkyl glycosides such as cetearyl
- Prolipid 141 which lists behenyl alcohol, glyceryl stearate, palmitic acid, stearic acid, myristyl alcohol, lauryl alcohol, cetyl alcohol and lecithin as its ingredients in its Formula Data Sheet.
- suitable anionic surfactants are soaps including, for example and without limitation, alkali soaps, such as sodium, potassium and ammonium salts of aliphatic carboxylic acids, usually fatty acids, such as sodium stearate.
- Organic amine soaps include, for example and without limitation, organic amine salts of aliphatic carboxylic acids, usually fatty acids, such as triethanolamine stearate.
- Metallic soaps include salts of polyvalent metals and aliphatic carboxylic acids, usually fatty acids, such as aluminum
- anionic surfactants include, for example and without limitation, sulfated fatty acid alcohols such as sodium lauryl sulfate, sulfated oils such as the
- sulfuric ester of ricinoleic acid disodium salt and sulfonated compounds such as alkyl sultanates including sodium cetane sulfonate, amide sulfonates such as sodium N-methyl-N-oleyl laurate, sulfonated dibasic acid esters such as sodium dioctyl sulfosuccinate, alkyl aryl sulfonates such as sodium
- the disclosed formulation/ formulations may contain a wide range of additional, optional components.
- CTFA Cosmetic Ingredient Handbook Seventh Edition, 1997, and the Eighth
- waterproofing agents are polyurethane polymers. Some such polymers are described, for example, in U.S. Pat. No. 7,097,828.
- the disclosed formulation may include foam stabilizers or foam stabilizing agents.
- foam stabilizers include, for example and without limitation, the Avicels, Capmul S12L, Capmul S18L,
- alcoholic extracts may be prepared for
- a pH modifier may be part of the disclosed
- Such sunless tanning compositions typically comprise, in addition to an artificial tanning
- the disclosed whipped formulation product has been developed, in part, to offer consumers a unique and better way to apply topical products such as sunscreen and after sun products to themselves and others.
- the disclosed whipped formulation product can allow for more control of spread over body.
- the disclosed whipped formulation product provides a more rigid "push" providing enhanced tactile response.
- the disclosed whipped formulation product provides a more rigid "push" providing enhanced tactile response.
- the disclosed whipped formulation product provides for faster application due to perceived fast absorption.
- the disclosed whipped formulation product with its pressured system allows for elevated levels of gas to be
- the disclosed whipped formulation product results in reduced corrosion potential by separating the
- spreadable formulation and thus may be particularly well suited for sensitive or compromised skin applications, such as applying a whipped sunscreen product.
- the disclosed whipped product form is designed to dispense, for example and without limitation,
- Sensory impact (such as appearance, sound, and skin impact) to the user may be evaluated by trained personnel to determine how product variants are perceived differently by the user, with statistical confidence. Those formulations determined to have high sensory impact are thus selected. High sensory impact is, for example, an impact to the user's senses that is greater than adequate. In certain embodiments, the user's senses are highly satisfied by the disclosed formulation after its application on the user.
- pre-gas can pressure, which influences stability of gas
- Sensory impact such as appearance, sound, and skin impact
- Sensory impact to the user of these multiple product variants may be evaluated by trained personnel to determine how product variants are perceived differently by the user, with statistical confidence.
- Some of these tested whipped formulations would have high sensory impact to the user.
- the following parameters, as well as any other parameters that impact a user's sense (s) may be evaluated.
- Appearance visual compactness, integrity of shape, gloss, hue, intensity, brightness, opacity, whitening.
- Sound volume, tone, crackling/popping, sputtering.
- Skin Feel firmness, stickiness, cohesiveness , peaking, wetness, spread-ability, coolness, thickness, slipperiness , oiliness, waxiness, greasiness, rubs to absorbency, tautness, roughness, thickness of residue, grittiness, graininess, chalkiness, peeling/ flaking, pilling, powdery-ness , plastic/coated.
- the whipped formulations have high sensory impact to a user, who may be a human user.
- These formulations with high sensory impact are characterized by one or more of the following: positive appearance, low sound impact, high integrity of shape, visual compactness, high spreadability, positive skin feel, afterfeel (immediately after application or after a few minutes after application, such as about 10 minutes after) as well as other sensory input perceivable by a user.
- the disclosed whipped product offers an easier, faster, smoother, and less greasy skincare formulation than a traditional formulation.
- the disclosed formulation has one or more of the following physical characteristics: a majority of bubbles being of a bubble size of less than 20 ⁇ , mean number of bubbles of about less than 20%, and high foam stability. In certain embodiments, the disclosed formulations have high foam stability at high temperatures, such as at 25°C to 37°C, or 37°C to 50°C.
- the color of the whipped formulation post-dispensing is white.
- the whiteness of the whipped lotion may be used as a visual queue for application on skin .
- the whipped formulation product is highly emollient. In certain embodiments, the whipped formulation product has about 60% or more of the gas bubbles at ⁇ 100 ⁇ . In certain other embodiments, the whipped formulation product has about 40% or more of the gas bubbles at ⁇ 60 ⁇ . The gas bubbles are formed from the gas propellant co-mingled with the formulation prior to filling the formulation into the package .
- the formulation has one or more of characteristics such as little or no wetness after application, having a collapse time of at least 60 seconds, or structurally stable for at least 30 minutes.
- (Finished Product) should be prepared by 1) pre-mixing step: co- process of a base formulation (Concentrate) and a 1st Gas, 2) pre-pressurizing step: pressurizing of a 2nd gas between a bag and the inside wall of the product can, and 3) packaging step: packaging the pre-mixed formulation (concentrate + the 1st gas) into the pre-pressurized Bag on Valve (BOV) package.
- pre-pressurized BOV package and the pre-mixing step were not utilized.
- the mixture of a base formulation and nitrous oxide in a package was shaken vigorously before
- formulations are able to deliver stable "whipped-foams" after remaining at room temperature (RT) for 24 hours.
- control (+++) > the control minus Cetyl alcohol (+++) > the control minus Avicel (++) the control minus
- Whipped sunscreen formulations with behenyl alcohol concentration ranging from 1.2 % w/w to 8.7 % w/w are prepared and evaluated for their stability at the high temperature (50° C/75%RH for 1 day) .
- Each whipped lotion formulation contains 4.50 % w/w Prolipid 141.
- Table 3 lists the concentration for each of the ingredients in the prolipid 141 per each whipped lotion formulation.
- increasing the concentration of behenyl alcohol from 1.2 % w/w to 6.2 % w/w significantly improves the stability of the whipped formulations for 50° C storage. Maximum improvement is achieved by the formulation containing 6.2% w/w behenyl alcohol.
- a whipped after sun lotion also delivers a voluminous and creamy "whipped- foam” at RT .
- the "whipped- foam” delivered from whipped after sun lotion losts its
- the minimum concentration of behenyl alcohol required to maintain the adequate "whipped- foam” stability at the high temperature (at 50°C) needs to be > 1.0 % w/w. No enhancement of "whipped-foam” stability was observed when behenyl alcohol concentration is increased from 0.5 % w/w to 1.0 % w/w.
- the score of "whipped-foam” from whipped after sun formulations containing different amount of behenyl alcohol (BA) after 1 day at 50°C/75%RH is as follows.
- Table 1 Formula Comparison of Whipped Sunscreen Products Used in Evaluation Studies
- Table l.A Composition of Whipped Sunscreen Products (Finished Products)
- Each whipped lotion formulation contains 4.50 % w/w Prolipid 141.
- Table 3 lists the concentration for each of the ingredients in the prolipid 141 per each whipped lotion formulation
- Appendix B Laboratory manufacturing process for Whipped After Sun Lotion (Finished Product: Z16-023,
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Abstract
Description
Claims
Priority Applications (7)
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CN201780028415.1A CN110035663A (en) | 2016-05-11 | 2017-05-11 | The heat-staple preparation for breaking into foam |
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US11612551B2 (en) | 2016-05-11 | 2023-03-28 | Formulated Solutions, Llc | Whipped formulations |
US11826440B2 (en) | 2016-05-11 | 2023-11-28 | Formulated Solutions, Llc | Thermal-stable whipped formulations |
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CA3117776A1 (en) * | 2018-10-24 | 2020-04-30 | Beiersdorf Ag | Sunscreen formulation |
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US11622922B2 (en) | 2016-05-11 | 2023-04-11 | Formulated Solutions, Llc | Whipped formulations |
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US11602493B2 (en) | 2017-05-11 | 2023-03-14 | Beiersdorf Ag | Gel formulations |
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CA3023703A1 (en) | 2017-11-16 |
AU2017263531A2 (en) | 2019-03-21 |
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BR112018073118B1 (en) | 2023-02-14 |
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BR112018073118A2 (en) | 2019-05-21 |
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CA3023669A1 (en) | 2017-11-16 |
EP3454826B1 (en) | 2023-11-15 |
EP3454826A1 (en) | 2019-03-20 |
WO2017197196A1 (en) | 2017-11-16 |
AU2017263531A1 (en) | 2018-10-11 |
US11964035B2 (en) | 2024-04-23 |
CN110035663A (en) | 2019-07-19 |
MX2018013757A (en) | 2019-09-09 |
US11826440B2 (en) | 2023-11-28 |
EP3454662A1 (en) | 2019-03-20 |
EP3454826C0 (en) | 2023-11-15 |
BR112018073125A2 (en) | 2019-05-21 |
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